Identify the critical elements of informed consent and strategies for implementing informed consent for clinical research.

Describe the purpose, function, and challenges of IRBs.

Appreciate the experience of human subjects who have participated in research protocols.

Background Requirements

There are no background requirements in terms of education, knowledge, or experience, just an interest in clinical research with human subjects. This course is readily accessible to the non-medically trained as well as to those in the field of scientific research. As a rule, background education includes a mix of MD, PhD, RN, MPH, SW, MPH, and BA/BS.

Bioethics is the study of the typically controversial ethical issues emerging from new situations and possibilities brought about by advances in health care, biology and medicine. It is also moral discernment as it relates to medical/nursing policy and practice.

Cost/Confidentiality

There is no fee for this course. The textbook, The Ethical and Regulatory Aspects of Clinical Research (JHU Press) is optional.

The course is divided into three parts, namely A. ethics, B. bioethics and C. faith-based bioethics.

Basic Ethical Principles

B. Basic Ethical Principles

The expression “basic ethical principles” refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions. Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.

1. Respect for Persons. — Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons’ considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person’s considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.

However, not every human being is capable of self-determination. The capacity for self-determination matures during an individual’s life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.

Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm them; other persons require little protection beyond making sure they undertake activities freely and with awareness of possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different situations.

In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information. In some situations, however, application of the principle is not obvious. The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners be protected. Whether to allow prisoners to “volunteer” or to “protect” them presents a dilemma. Respecting persons, in most hard cases, is often a matter of balancing competing claims urged by the principle of respect itself.

2. Beneficence. — Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term “beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.

The Hippocratic maxim “do no harm” has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others. However, even avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed to risk of harm. Further, the Hippocratic Oath requires physicians to benefit their patients “according to their best judgment.” Learning what will in fact benefit may require exposing persons to risk. The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks.

The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. In the case of particular projects, investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation. In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.

The principle of beneficence often occupies a well-defined justifying role in many areas of research involving human subjects. An example is found in research involving children. Effective ways of treating childhood diseases and fostering healthy development are benefits that serve to justify research involving children — even when individual research subjects are not direct beneficiaries. Research also makes it possible to avoid the harm that may result from the application of previously accepted routine practices that on closer investigation turn out to be dangerous. But the role of the principle of beneficence is not always so unambiguous. A difficult ethical problem remains, for example, about research that presents more than minimal risk without immediate prospect of direct benefit to the children involved. Some have argued that such research is inadmissible, while others have pointed out that this limit would rule out much research promising great benefit to children in the future. Here again, as with all hard cases, the different claims covered by the principle of beneficence may come into conflict and force difficult choices.

3. Justice. — Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of “fairness in distribution” or “what is deserved.” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort,(4) to each person according to societal contribution, and (5) to each person according to merit.

Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research. However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the 1940’s, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.

B. Basic Bioethics from the USA government (gov)

Against a historical background, it can be seen how conceptions of justice are relevant to research involving human subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.

Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

The principles are intended to illuminate and guide public policy choices to ensure that new technologies, including synthetic biology, can be developed in an ethically responsible manner. The ideal of public beneficence is to act to maximize public benefits and minimize public harm. This principle encompasses the duty of a society and its government to promote individual activities and institutional practices, including scientific and biomedical research, that have great potential to improve the public’s well-being. Public beneficence requires that when seeking the benefits of synthetic biology, the public and its representatives be vigilant about risks and harms, standing ready to revise policies that pursue potential benefits with insufficient caution.

The principle of responsible stewardship reflects a shared obligation among members of the domestic and global communities to act in ways that demonstrate concern for those who are not in a position to represent themselves (e.g., children and future generations) and for the environment in which future generations will flourish or suffer. Responsible stewardship recognizes the importance of citizens and their representatives thinking and acting collectively for the betterment of all. Importantly, it calls for prudent vigilance, establishing processes for assessing likely benefits along with assessing safety and security risks both before and after projects are undertaken. A responsible process will continue to assess safety and security as technologies develop and diffuse into public and private sectors. It will also include mechanisms for limiting their use when necessary. executive summary 5 Democracies depend on intellectual freedom coupled with the responsibility of individuals and institutions to use their creative potential in morally accountable ways. Sustained and dedicated creative intellectual exploration begets much of our scientific and technological progress.

While many emerging technologies raise “dual use” concerns—when new technologies intended for good may be used to cause harm—these risks alone are generally insufficient to justify limits on intellectual freedom. As a corollary to the principle of intellectual freedom and responsibility, the Commission endorses a principle of regulatory parsimony, recommending only as much oversight as is truly necessary to ensure justice, fairness, security, and safety while pursuing the public good. This is particularly important in emerging technologies, which by their very definition are still in formation and are not well suited for sharply specified limitations. While clear guidelines to protect biosecurity and biosafety are imperative, undue restriction may not only inhibit the distribution of new benefits, but it also may be counterproductive to security and safety by preventing researchers from developing effective safeguards.

The principle of democratic deliberation reflects an approach to collaborative decision making that embraces respectful debate of opposing views and active participation by citizens. It calls for individuals and their representatives to work toward agreement whenever possible and to maintain mutual respect when it is not. Public discussion and debate with open interchange among all stakeholders can promote the perceived legitimacy of outcomes, even if those outcomes are unlikely to satisfy all interested parties. An inclusive process of deliberation, informed by relevant facts and sensitive to ethical concerns, promotes an atmosphere for debate and decision making that looks for common ground wherever possible and seeks to cultivate mutual respect where irreconcilable differences remain. It encourages participants to adopt a societal perspective over individual interests.

The principle of justice and fairness relates to the distribution of benefits and burdens across society. Biotechnology and emerging technologies such as synthetic biology, for good or ill, affect all persons. Emerging technologies like synthetic biology will have global impacts. For this reason, every nation has a responsibility to champion fair and just systems to promote wide availability of information and fairly distribute the burdens and benefits of new technologies.

“When most people think of ethics (or morals), they think of rules for distinguishing between right and wrong, such as the Golden Rule (“Do unto others as you would have them do unto you”), a code of professional conduct like the Hippocratic Oath (“First of all, do no harm”), a religious creed like the Ten Commandments (“Thou Shalt not kill…”), or a wise aphorisms like the sayings of Confucius. This is the most common way of defining “ethics”: norms for conduct that distinguish between acceptable and unacceptable behavior…”

By David B. Resnik, J.D., Ph.D. From the National Institute of Environmental Health Sciences

C. Faith-based Bioethics

Golden Rule Reasoning, Moral Judgement and Law
Neil Duxbury Abstract

This article examines ‘Golden Rule reasoning’ – reasoning according to the principle that we should treat others as we would have them treat us – as a basis for moral action and as a criterion for assessing the moral quality and implications of laws. After distinguishing the Golden Rule from other ideas and principles with which it is sometimes associated, I embark upon a defence of the Golden Rule as a principle of fairness. The main approach to defending this principle has been to detach Golden Rule-based behaviour from the desires of agents and recipients. The purpose of adopting this approach is to avoid reducing the Golden Rule to the proposition that we are entitled to impose on others preferences that we would happily have imposed on us. I examine various attempts to show that the Golden Rule requires that agents do not simply project their values and desires onto others and I argue that the most successful of these is R. M. Hare’s explanation of Golden Rule reasoning in universal prescriptivist terms. Although the universal prescriptivist explanation is open to various criticisms – as becomes obvious when it is applied to particular moral problems such euthanasia and abortion – it nevertheless provides a strong philosophical basis for claiming not only that Golden Rule reasoning need not be connected to particular tastes and preferences but also that, as a matter of moral principle, we should never tolerate double standards where cases are relevantly similar. While I accept and try demonstrate the merits of interpreting the Golden Rule in universal prescriptivist terms, however, I conclude that a more robust interpretation of the Rule is one which is advanced by some natural law philosophers and which has it that doing to others as one would have done to oneself is necessarily a case of doing good towards others. The article ends with some reflections on the implications this version of Golden Rule reasoning for legal policy-making, and in particular for the abortion debate.

What is Christian about Christian bioethics?

What is Christian about Christian bioethics? The short answer to this question is that the Incarnation should shape the form and content of Christian bioethics. In explicating this answer it is argued that contemporary medicine is unwittingly embracing and implementing the transhumanist dream of transforming humans into posthumans. Contemporary medicine does not admit that there are any limits in principle to the extent to which it should intervene to improve the quality of human life. This largely inarticulate, yet ambitious, agenda is derived first in late modernity’s failed, but nonetheless ongoing, attempt to transform necessity into goodness, and second the loss of any viable concept of eternity, thereby stripping temporal existence of any normative significance. In short, medicine has become the vanguard of a profane attempt to save humankind by extracting data from flesh. In response, it is contended that an alternative Christian bioethics must be shaped by the Incarnation, the Word made flesh. This assertion does not entitle Christians to oppose the posthuman trajectory of contemporary medicine on the basis of any natural or biological essentialism. Rather, it is an evangelical witness to the grace of Christ’s redemption instead of the work of self-transformation. It is Christ alone who thereby makes the vulnerability and mortality of finitude a gift and blessing. Specifically, it is maintained that the chasm separating necessity and goodness cannot be filled but only bridged through the suffering entailed in Christ’s cross, and through Christ’s resurrection eternity becomes the standard against which the temporal lives of human creatures are properly formed and measured. Consequently, Christian bioethics should help us become conformed to Christ rather than enabling self-transformation.

All ethics has a religious dimension. This paper considers how specific Christian insights concerning death, suffering, human nature and human creatureliness can help to expose morefully the moral issues at stake in some ofthe dilemmas faced by doctors. It ends by acknowledging the crushing burden of decision-making which rests on many in the medical profession, and indicates the importance of religious resources in dealing with this. I start with the bald assertion that all ethics, including medical ethics, has a theological dimension. This is because all serious ethical discussion pushes us back to questions about ultimate beliefs and values – the very stuff of religion.

Theology is the attempt to articulate such questions, to relate them to the thinking of those who have faced them in their classic forms, and to make sense of them in the context of today’s world. It thus forms an essential background to rational ethical thought. I say this briefly, and without arguing the point, because people have such varied ideas about what theology is, and therefore about the kind of contribution a theologian might be expected to make to the discussion of medical ethics. There may be suspicions that theologians come armed with some predetermined set of answers which simply have to be applied to the cases in hand.

There may be a suspicion, too, that theology is a kind of optional extra, as if one can avoid theological questions simply by ignoring them. But ultimate questions, questions about life and death, about meaning and purpose, about the source of our hopes and values and the things which ultimately matter to us, such questions keep intruding whether we want them to or not. And the usual alternative to a thought-out theology is an unthought-out theology. What I want to suggest is that proper attention to the theological dimension in ethics can help to open up ethical problems, can reveal unexpected depths in them, can be a source of awkward questions, and can help to give shape and coherence to the sense of values with which we tackle them.